Hemostatic Efficacy and Safety of Weight-Based Versus Fixed-Dose 4F-PCC for Vitamin K Antagonist Reversal.

Autor:	Milkovits AE; Clinical Pharmacy Specialist, Department of Pharmacy, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA., Sugrue D; Clinical Pharmacy Coordinator, Duke Raleigh Hospital, Raleigh, NC, USA., Faris J; Clinical Pharmacy Specialist, Parkland Health, Dallas, TX, USA., Schad JL; Clinical Pharmacy Specialist, Department of Pharmacy, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA., McAllister KB; Clinical Pharmacy Manager, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA.
Jazyk:	angličtina
Zdroj:	Journal of pharmacy practice [J Pharm Pract] 2024 Oct; Vol. 37 (5), pp. 1099-1106. Date of Electronic Publication: 2024 Jan 19.
DOI:	10.1177/08971900241228779
Abstrakt:	Background: Four-factor prothrombin complex concentrate (4F-PCC) is indicated for vitamin K antagonist (VKA) reversal but is associated with thrombotic events (TE). In 2018, the institution revised 4F-PCC dosing for VKA reversal from INR and weight-based dosing to a fixed-dose of 1500 units. Objective: The purpose of this study was to compare hemostatic efficacy and TE rate of fixed-dose 4PCC to weight-based dosing. Methods: This was a retrospective, single-center, quasi-experimental study of adult patients who received 4F-PCC for VKA reversal from January 2014 through May 2016 (INR and weight-based dosing) or April through October 2018 (fixed-dosing). The primary endpoint was hemostatic efficacy, defined by achieving an INR of ≤1.4, or an INR of ≤1.7 with evidence of hemostasis. The key secondary endpoint was TE within 14 days of 4F-PCC administration. Data were analyzed using descriptive statistics, chi-squared for nominal data and Mann-Whitney U for ordinal and continuous data. Results: The study included 163 patients who received weight-based dosing and 45 who received fixed-dose 4F-PCC. Hemostatic efficacy was 76.9% of patients in the weight-based group and 77.4% of patients in the fixed-dose group ( P = .229). TE occurred in 13.5% of the weight-based vs 6.7% of the fixed-dose group ( P = .181). Conclusion: This study found no difference in hemostatic efficacy with fixed-dose 4F-PCC for VKA reversal compared to INR and weight-based dosing. The occurrence of TE was reduced by 50% with the 4F-PCC fixed-dose strategy; however, this difference was not statistically significant. Further randomized studies are needed to confirm these results. Competing Interests: Declaration of Conflicting IinterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu